Director Quality Assurance
Director Quality Assurance
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Job Description
Job Summary:
The Director of Quality Assurance is a leadership role responsible for all aspects of the Quality Systems Manufacturing Quality and Quality Control Laboratory for Aquestive. The Director of Quality Assurance will work with their direct managerial reports as well as Executive Leadership for ensuring a continued state of compliance while promoting a strong quality culture across the organization for all products spanning early phase development to commercialization.
This position will be expected to work in a highly collaborative cross functional team environment and provide expert knowledge to risk identification/mitigation strategy and .
Responsibilities:
- Oversee all aspects of Quality Systems Manufacturing Quality and Quality Control Laboratory to assure compliance with FDA EU ANVISA TGA and other international GMP requirements for all products manufactured at Aquestive (e.g. 21 CFR Part 210 211 EU GMP Volume 4 Part 1.
- Provide strategic direction and leadership to ensure effectiveness of Quality Systems (e.g. CAPA Change Management Event Management Supplier Quality Internal Audit Document Management Risk Management Record Review and Product Disposition Training Field Alert/Recall etc.
- Provide strategic direction and leadership of all aspects of the Quality Control Laboratory in support of stability raw materials inprocess drug substance and finished products.
- Provide expert technical support for method development transfers qualification validation and laboratory out of trend (OOT) and out of specification (OOS) investigations.
- Lead and ensure of quality strategy for all development and manufacturing activities associated with all products manufactured by Aquestive including external GMP contract manufacture operations or laboratories for drug substance and drug product.
- Primary contact for all inspection interactions with all domestic and exUS regulatory authorities.
- Provide direction for escalated quality issues as they arise determining the need for and structuring communication for further escalation to the Executive team and/or external parties.
- Lead strategic quality to quality relationships with business partners suppliers external CMOs and thirdparty testing laboratories.
- Ensure company is upholding to Quality/Technical Agreements with business partners and suppliers.
- Actively participate on the Site Leadership Team to drive continuous improvement activities and initiatives throughout Aquestive.
- Lead inspection strategies for cGMP sites ensuring auditreadiness at all times.
- Manage overall coaching training development and succession planning for the function.
Qualifications:
- Minimum of Bachelors degree required. Advanced degree in chemistry engineering biochemistry or related science field desirable.
- Minimum 7 years of related work experience working in a regulated GxP industry in pharmaceutical manufacturing operation setting or service oriented laboratory.
- Demonstrated ability to direct a function oversee projects and teams. Minimum of 2 years overseeing direct reports.
- Minimum of 2 years working in a managerial role with direct reports.
- Strong skillset in problem solving strategic thinking critical reasoning and decision making.
- Strong interpersonal skills and verbal/written communication skills.
- Excellent computer skills required (e.g. Microsoft Word Excel Access PowerPoint Visio).
- Strong project management skills strong organizational skills to maintain a high level of productivity innovation and prioritysetting to complete assignments on time and on budget.
- Strong business acumen surrounding pharmaceutical manufacturing.
- Some travel required.
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities duties and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestives employment process final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drugfree workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race color religion age sex national origin disability status genetics protected veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Required Experience:
Director
Employment Type
Full-Time
